Oct. 16, 2009 (Baltimore) -- Researchers believe that there may be a link
between a vaccine against cervical cancer and a rapidly
progressive, fatal disease in two young women.

Both the timing of the symptoms and autopsy results "suggest a link between"
the Gardasil vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known
as Lou Gehrig's disease, says Catherine Lomen-Hoerth, MD, director of the
ALS Center at University of California San Francisco Medical Center.

With only two confirmed cases, "we don't know for sure if it's coincidence
or if they're connected [to the vaccine]," she tells WebMD. "We hope that by
raising awareness, we will become aware of any other cases."

Pam Eisele, a spokeswoman for Merck & Co., which makes the vaccine, says
the company cannot comment specifically on the cases as it has not seen the
data.

"However, after carefully reviewing all the information available to us
about reported adverse events, including reports of deaths, Merck does not
believe these events have been caused by Gardasil," she says.

The vaccine has been given to more than 7 million girls and young women
nationwide.

Gardasil and ALS: Jenny's Story

The tragic story of one of the girls, Jenny Tetlock, is chronicled on
"Jenny's Journey," a web site created by her parents to publicize her case and
get others with similar symptoms to come forward.

The first sign that something was wrong was when 14-year-old Jenny tripped
on a hurdle that others in her class cleared easily, according to the web site.
That was just months after her third and final booster Gardasil shot,
Lomen-Hoerth says.

The disease rapidly progressed; both her legs, and then her arms became
weak, Lomen-Hoerth continues. Jenny began to limp and had trouble gripping
objects. She felt pins and needles in her feet, and her muscles atrophied, she
tells WebMD.

Within a year, Jenny was paralyzed, a quadriplegic breathing only with the
help of life support. She died shortly afterward, Lomen-Hoerth says.

Throughout the course of her illness, Jenny's mind was as sharp as ever, she
adds.

The other patient, a 20-year-old, developed similar symptoms within four
months of her first Gardasil shot, Lomen-Hoerth says. The disease followed a
similar course, and the girl died 28 months later.

Rapidly Progressive Course

In addition to the short time span between vaccination and the onset of
symptoms, several other factors made the researchers suspect a link to Gardasil
vaccination, Lomen-Hoerth says.

In both young women, the disease progressed more quickly than typical for
young ALS patients, she says.

Additionally, at autopsy, "we were surprised that the spinal cord was so
inflammatory. That is very different from what we normally see in ALS," she
says.

The pathology features "all support a temporal association between [the
illness] and vaccination," Lomen-Hoerth says.

She spoke at the annual meeting of the American Neurological
Association.

Because it is extremely rare, affecting just one in 2-3 million young
people, there are very few studies of juvenile ALS, Lomen-Hoerth says.

Her team plans further study comparing the symptoms and pathological
features of young adults with ALS who got the Gardasil vaccine to those who
didn't get the shots. "If the features are identical, then we'll know [the
vaccine] is not the cause," Lomen-Hoerth says.

In the meantime, she and colleagues have met with scientists from the FDA
and CDC to scour their adverse-event database, called the Vaccine Adverse Event
Reporting System (VAERS), for any other reports linking ALS to Gardasil or
other vaccinations. "So far, we haven't found any," she says.

Merck is also continuing to work with the CDC and FDA to monitor any adverse
events that may have been caused by the vaccine, according to Eisele.

Yadollah Harati, MD, a neurologist at Baylor College of Medicine in Houston,
says the findings raise a red flag.

The fact that "the postmortem studies show distinct immunological features
different from what is typical of ALS" suggest an association between
vaccination and ALS, he says.

"I will be asking any of my young patients with ALS whether they received
the Gardasil vaccine," he tells WebMD. "I have one 20-year old ALS patient, and
we didn't think to ask that."